SchizophreniaPhase 1NCT01423916

Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

A Phase 1 study testing OPC-34712 (4mg), Moxifloxacin and OPC-34712 (12mg) in people with Schizophrenia and Schizoaffective Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: OPC-34712 (4mg), Moxifloxacin and OPC-34712 (12mg)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 218 participants
Where: 8 sitesUnited States
Study dates: Jul 2011to Mar 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male and female subjects between 18 and 55 years of age, inclusive, with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria.
Body mass index of 19 to 35 kg/m2.

Who cannot join

Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of trial medication for all female subjects.
Subjects presenting with a first episode of schizophrenia or schizoaffective disorder based on the clinical judgment of the investigator.
Subjects who have received continuous medication therapy to treat schizophrenia or schizoaffective disorder for less than 6 months prior to washout.
Subjects with schizophrenia or schizoaffective disorder that are considered resistant/refractory to antipsychotic treatment by history, who have a history of failure to clozapine, or who are responsive only to clozapine treatment.
Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder.
Hospitalization for an exacerbation of schizophrenia or schizoaffective disorder within 3 months prior to randomization.

Show all 10Show fewer

Subjects who have a history of or who have evidence of other medical and/or neurological conditions that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the trial.
Subjects with a history of neuroleptic malignant syndrome.
Subjects with a history of seizure disorder.
Subjects who meet DSM-IV-TR criteria for substance dependence within 6 months prior to randomization.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Otsuka Investigational Site
Austin, Texas, 78754
Otsuka Investigational Site
Fort Lauderdale, Florida, 33308
Otsuka Investigational Site
Long Beach, California, 90806
Otsuka Investigational Site
Overland Park, Kansas, 66212
Otsuka Investigational Site
Philadelphia, Pennsylvania, 19139
Otsuka Investigational Site
Rockville, Maryland, 20850
Otsuka Investigational Site
San Diego, California, 92102
Otsuka Investigational Site
St Louis, Missouri, 63118

Other trials in United States

About this study

Official title: A Parallel-arm, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder

To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo
To determine the effect of moxifloxacin on QTcI
To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: OPC-34712 (4mg), Moxifloxacin, OPC-34712 (12mg), Placebo
Keywords: Schizophrenia, QTc Interval
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-34712 (4mg)Drug
Arms assigned to this intervention receive 4mg.
MoxifloxacinDrug
Arms assigned to this intervention will receive 400mg.
OPC-34712 (12mg)Drug
Arms assigned to this intervention receive 12mg.
PlaceboDrug
OPC-34712 placebo

Study groups in NCT01423916
Study group	Role	What they receive
Arm 1 (OPC-34712, placebo)	Active comparator	Arm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day. Receives: Drug: OPC-34712 (4mg); Drug: Placebo
Arm 2 (OPC-34712, placebo)	Active comparator	Arm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day. Receives: Drug: OPC-34712 (12mg); Drug: Placebo
Arm 3 (moxifloxacin, placebo)	Active comparator	Arm 3 will be administered 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for 1 day and OPC-34712 placebo QD for 11 days. Receives: Drug: Moxifloxacin; Drug: Placebo
Arm 4 (moxifloxacin, placebo)	Active comparator	Arm 4 will be administered OPC-34712 placebo QD for 11 days and 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for one day. Receives: Drug: Moxifloxacin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Measured: Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.
Measured: AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication
Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.
Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Measured: Day 11
Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.
Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Measured: Day 11
Area Under the Plasma Concentration-time Curve During Dosing (AUCT).
Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Measured: Day 11

Secondary outcomes (8)

Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.
New onset (> 450, > 480, or > 500 msec) in QTc was defined as a participant who attained a QTc > 450, > 480, > 500 msec during Day 11 but not on Day -1. The number of participants were noted with time-matched change in mean QTcI change from Baseline for assay sensitivity of moxifloxacin treatment corrected for placebo. The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Measured: Baseline, Day 11
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change form Baseline in summary of maximun QTcI on Day 11 minus mean QTcI on Day -1 (Baseline) is presented here.
Measured: Baseline, Day 11
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change from Baseline in summary of maximum QTcI on Day 11 minus maximum QTcI on Day -1 (Baseline) is presented here.
Measured: Baseline, Day 11
Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change between 30 to 60 msec were presented here.
Measured: Day 11
Number of Participants With QTcI Interval > 60 Msec on Day 11.
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change of > 60 msec on Day 11 were presented here.
Measured: Day 11
Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.
The number of participants who were noted with new incidence of QT interval of > 500 msec on Day 11 and a 12-lead ECG was used.
Measured: Day 11
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Participants with incidence of ECG morphology abnormalities on Day 11 (participants who had abnormalities during Day 11 but not at Day -1) were noted. Types of abnormalities included appearance of abnormal U waves, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, and left bundle branch block. ECGs were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.
Measured: Day 11
Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.
Changes in HR with values 25% decrease from Day -1 and HR < 50 bpm and 25% increase from Day -1 and HR > 100 bpm; PR interval of greater than or equal to 25% change from Day -1 and PR > 200 msec; QRS interval of Greater than or equal to 25% change from Day -1 and > 100 msec were noted on Day 11. Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate.
Measured: Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Mar 2012

First posted26 Aug 2011 (estimated)
Study startJul 2011
Primary completionFeb 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01423916
Sponsor's protocol ID: 331-10-242
Status last verified: Sep 2015
First submitted: 8 Aug 2011
Last updated: 29 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Parallel-arm, Double-blind, Placebo and Positive Controlled Multiple Oral Dose Administration Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
ClinicalTrials.gov ID: NCT01423916
Acronym / sponsor ID: 331-10-242
Conditions: Schizophrenia, Schizoaffective Disorder
Keywords: Schizophrenia, QTc Interval
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Feb 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 26 Aug 2011 (estimated)
Results: Posted 29 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo
To determine the effect of moxifloxacin on QTcI
To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Arm 1 (OPC-34712, placebo)	Active comparator	Drug: OPC-34712 (4mg), Drug: PlaceboArm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day.
Arm 2 (OPC-34712, placebo)	Active comparator	Drug: OPC-34712 (12mg), Drug: PlaceboArm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day.
Arm 3 (moxifloxacin, placebo)	Active comparator	Drug: Moxifloxacin, Drug: PlaceboArm 3 will be administered 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for 1 day and OPC-34712 placebo QD for 11 days.
Arm 4 (moxifloxacin, placebo)	Active comparator	Drug: Moxifloxacin, Drug: PlaceboArm 4 will be administered OPC-34712 placebo QD for 11 days and 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for one day.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male and female subjects between 18 and 55 years of age, inclusive, with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria.
Body mass index of 19 to 35 kg/m2.

Key exclusion criteria (10 listed)

Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of trial medication for all female subjects.
Subjects presenting with a first episode of schizophrenia or schizoaffective disorder based on the clinical judgment of the investigator.
Subjects who have received continuous medication therapy to treat schizophrenia or schizoaffective disorder for less than 6 months prior to washout.
Subjects with schizophrenia or schizoaffective disorder that are considered resistant/refractory to antipsychotic treatment by history, who have a history of failure to clozapine, or who are responsive only to clozapine treatment.
Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia or schizoaffective disorder.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-34712 (4mg)Arms assigned to this intervention receive 4mg.	Drug	Arm 1 (OPC-34712, placebo)
MoxifloxacinArms assigned to this intervention will receive 400mg.	Drug	Arm 3 (moxifloxacin, placebo), Arm 4 (moxifloxacin, placebo)
OPC-34712 (12mg)Arms assigned to this intervention receive 12mg.	Drug	Arm 2 (OPC-34712, placebo)
PlaceboOPC-34712 placebo	Drug	Arm 1 (OPC-34712, placebo), Arm 2 (OPC-34712, placebo), Arm 3 (moxifloxacin, placebo), Arm 4 (moxifloxacin, placebo)

Primary outcome

Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Time frame: Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)
Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Time frame: AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication
Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.
Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.
Time frame: Day 11
Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.
Time frame: Day 11
Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Area Under the Plasma Concentration-time Curve During Dosing (AUCT).
Time frame: Day 11
Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.

8 secondary outcomes

Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.
Time frame: Baseline, Day 11
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).
Time frame: Baseline, Day 11
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).
Time frame: Baseline, Day 11
Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.
Time frame: Day 11
Number of Participants With QTcI Interval > 60 Msec on Day 11.
Time frame: Day 11
Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.
Time frame: Day 11
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Time frame: Day 11
Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.
Time frame: Day 11

Results and safety

Results posted to the registry on 29 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brexpiprazole 4mg	74	63
Brexpiprazole 12mg	73	53
Moxifloxacin/Placebo	71	64

Primary outcome: Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.

Time frame: Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24). Mean (90% Confidence Interval). Unit: msec

Measure	Moxifloxacin/Placebo n = 64	Brexpiprazole 12mg n = 53	Brexpiprazole 4mg n = 63
Hours 1 (N=61, 53, 61)	9.2 (5.8 to 12.6)	-0.2 (-5.2 to 4.8)	2.6 (-2.2 to 7.4)
Hours 2 (N= 62, 53, 62)	9.4 (6.0 to 12.8)	-0.2 (-5.0 to 4.5)	1.2 (-3.4 to 5.7)
Hours 3 (N= 60, 51, 61)	8.5 (5.1 to 11.9)	1.3 (-3.4 to 6.0)	1.1 (-3.4 to 5.6)
Hours 4 (N= 62, 53, 62)	10.5 (7.1 to 13.8)	3.1 (-1.7 to 8.0)	3.6 (-1.0 to 8.3)
Hours 5 (N= 62, 52, 62)	6.2 (2.8 to 9.5)	-0.2 (-5.1 to 4.6)	1.7 (-2.9 to 6.3)
Hours 6 (N= 61, 52, 62)	7.3 (3.8 to 10.7)	1.3 (-3.5 to 6.1)	8.3 (-3.7 to 12.9)
Hours 8 (N= 59, 50, 59)	7.5 (4.1 to 10.9)	2.5 (-2.0 to 6.9)	4.0 (-0.2 to 8.3)
Hours 10 (N= 59, 47, 56)	9.0 (5.5 to 12.4)	2.2 (-2.3 to 6.8)	5.2 (0.8 to 9.5)

Population analysed: The dataset quantitates effect of brexpiprazole on individual QTcI corrected for placebo of the completer population where participants received study medication from Day 1 to Day 11 (placebo at Day 1) had 1 Predose and Post-dose time-matched ECG assessments on Day 1 and Day 11. The first 5 time points for moxifloxacin arm only were 2-sided 98% CI.

Primary outcome: Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).

Time frame: AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication. Number. Unit: participants

Measure	Brexpiprazole 4mg n = 70	Brexpiprazole 12mg n = 67	Moxifloxacin n = 65	Placebo n = 68
Postural orthostatic tachycardia syndrome	0	1	0	0
Tachycardia	0	0	2	1
Blood creatinine phosphokinase increased	1	1	0	0
Blood pressure increased	0	0	0	1
Blood prolactin increased	0	0	1	0
Hepatic enzyme increased	1	1	0	0
Liver function test abnormal	0	1	0	0
Weight increased	0	1	0	0

Population analysed: Safety dataset of randomized participants received 1 dose of study medication after Day 1.

Primary outcome: Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.

Time frame: Day 11. Mean (Standard Deviation). Unit: ng/mL

Measure	Brexpiprazole 4mg n = 63	Brexpiprazole 12mg n = 53	Moxifloxacin/ Placebo n = 64
Value	170 (69.8)	462 (249)	2760 (659)

Population analysed: Pharmacokinetics (PK) analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.

Primary outcome: Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.

Time frame: Day 11. Median (Full Range). Unit: Hours

Measure	Brexpiprazole 4mg n = 63	Brexpiprazole 12mg n = 53	Moxifloxacin/ Placebo n = 64
Value	3.54 (1.00 to 8.00)	3.00 (0.00 to 8.00)	1.25 (0.00 to 5.00)

Population analysed: PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brexpiprazole 4mg	1 of 70 (1.4%)	27 of 70 (38.6%)	Not reported
Brexpiprazole 12mg	0 of 67 (0%)	27 of 67 (40.3%)	Not reported
Moxifloxacin	0 of 65 (0%)	9 of 65 (13.8%)	Not reported
Placebo	0 of 68 (0%)	20 of 68 (29.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment. (time frame: Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01423916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.